FDA Regulatory Consultant for AI SaMD in Cardio Care

Regain; Chicago (IL); Remote; USD 120.000 - 180.000; Teilzeit

Zusammenfassung

Regain is seeking an FDA regulatory consultant for a remote, US-based role to shape regulatory strategy for autonomous AI medical software. The position offers a part-time consultant engagement with the option to convert to 0.3 FTE, aligning with ARPA-H ADVOCATE program milestones and multi-site validation requirements.

The role requires leading submissions, defining De Novo pathways, and ensuring QMS alignment.

Qualifikationen

• 5+ years FDA regulatory affairs experience.
• Led or contributed to at least one SaMD submission.
• AI/ML medical device regulatory knowledge preferred; Breakthrough Device Designation experience preferred.

Aufgaben

• Lead Pre-Submission strategy with FDA.
• Prepare and submit regulatory submissions (513(g), De Novo, BDD).
• Define De Novo regulatory roadmap for autonomous prescribing SaMD.
• Advise on QMS documentation (ISO 13485, IEC 62304).

Kenntnisse

FDA regulatory affairs

SaMD submissions

AI/ML medical devices

Regulatory strategy

Jobbeschreibung

Regain is seeking an FDA regulatory consultant for a remote, US-based role to shape regulatory strategy for autonomous AI medical software. The position offers a part-time consultant engagement with the option to convert to 0.3 FTE, aligning with ARPA-H ADVOCATE program milestones and multi-site validation requirements.

The role requires leading submissions, defining De Novo pathways, and ensuring QMS alignment.